INDIA
China
Pakistan
Nepal
Delhi
Bangladesh
India
Myanmar
Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani Lakshmikumaran & Sridharan Attorneys
Sri Lanka
Contents 1. Life Sciences Regulatory Framework p.137 1.1 Legislation and Regulation p.137 1.2 Challenging Decisions of Regulatory Bodies p.139 1.3 Categories of Pharmaceuticals and Medical Devices p.139 2. Clinical Trials p.140 2.1 Regulation of Clinical Trials p.140 2.2 Securing Authorisation to Undertake a Clinical Trial p.140 2.3 Public Availability of the Conduct of a Clinical Trial p.141 2.4 Use of Online Tools to Support Clinical Trials p.142 2.5 Use of Data From Clinical Trials p.142 2.6 Personal or Sensitive Data p.142 3. Marketing Authorisations p.142 3.1 Product Classification p.142 3.2 Marketing Authorisation for Biologic Medicinal Products p.143 3.3 Period of Validity of Marketing Authorisations p.143 3.4 Procedure for Obtaining a Marketing Authorisation p.144 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.145 3.6 Ongoing Obligations Imposed by Marketing Authorisations p.145 3.7 Third-Party Access to Pending Applications for Marketing Authorisations p.145 4. Regulatory Reliance and Fast-Track Registration Routes p.146 4.1 Fast-Track Registration Routes p.146 4.2 Regulatory Reliance p.146
5. Manufacturing of Pharmaceuticals and Medical Devices p.146 5.1 Requirement for Authorisation for Manufacturing Plants p.146 6. Distribution of Pharmaceuticals and Medical Devices p.147 6.1 Wholesale of Pharmaceuticals and Medical Devices p.147 6.2 Different Classifications Applicable to Pharmaceuticals p.147 7. Import and Export of Pharmaceuticals and Medical Devices p.147 7.1 Governing Law and Relevant Enforcement Bodies p.147 7.2 Importer of Record of Pharmaceuticals and Medical Devices p.148 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices p.148 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports p.148 7.5 Trade Blocs and Free Trade Agreements p.149 8. Pharmaceutical and Medical Device Pricing and Reimbursement p.149 8.1 Price Control for Pharmaceuticals and Medical Devices p.149 8.2 Price Levels of Pharmaceuticals or Medical Devices p.149 8.3 Reimbursement From Public Funds p.150 8.4 Cost-Benefit Analyses p.150 8.5 Regulation of Prescriptions and Dispensing by Pharmacies p.150
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